SOCRA Certification Exam Questions With Solved
Solutions
Does the FDA consider electronic signatures to be as trustworthy and reliable as
handwritten paper signatures? - ANSWER>>Yes (although permission to use such e-sigs
has to be approved by the FDA)
Does the FDA consider electronic records that meet requirements to be equivalent to
handwritten records ? - ANSWER>>Yes
Open system (FDA term) - ANSWER>>System access is NOT controlled by people who are
responsible for the content of the electronic records in the system. (Like me putting data
into CHOP - controlled databases)
Closed system (FDA term) - ANSWER>>Environment in which SYSTEM ACCESS is
controlled by the same people responsible for the content of the system (I.E. I control the
Robotic Database access AND its contents)
What are some FDA Standards to meet when operating a closed record system? -
ANSWER>>1. Must be able to tell if records have been altered or invalid
,2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
6. Use operational system checks and restrictions
7. Use authority checks to make sure only authorized individuals are using the system
8. Use device checks to validate data input
9. Make sure those authorized to use system have appropriate training, education,
experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
What are some FDA standards to meet when using an Open System? - ANSWER>>All those
mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - ANSWER>>1. Printed
name of signer
2. Date and Time when signature was executed
3. The MEANING associated with the signature (approval? responsibility? authorship?)
Signature and record linking ? - ANSWER>>Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
, Do researchers need to request permission from the FDA to use electronic signatures in
place of regular signatures? - ANSWER>>Yes
What controls should an E-SIGNATURE contain? - ANSWER>>Employ at least 2
identification components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification code and
password) for e-signature? - ANSWER>>1. no 2 people should have the same identification
controls (password... code)
2. Identification codes and passwords should be periodically checked, revised, etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - ANSWER>>NO! Cannot say
things like "you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT informed
consent? ((EMERGENCY USE)) - ANSWER>>1. the investigator and an independent
physician agree that the patient is -life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood of saving life
Solutions
Does the FDA consider electronic signatures to be as trustworthy and reliable as
handwritten paper signatures? - ANSWER>>Yes (although permission to use such e-sigs
has to be approved by the FDA)
Does the FDA consider electronic records that meet requirements to be equivalent to
handwritten records ? - ANSWER>>Yes
Open system (FDA term) - ANSWER>>System access is NOT controlled by people who are
responsible for the content of the electronic records in the system. (Like me putting data
into CHOP - controlled databases)
Closed system (FDA term) - ANSWER>>Environment in which SYSTEM ACCESS is
controlled by the same people responsible for the content of the system (I.E. I control the
Robotic Database access AND its contents)
What are some FDA Standards to meet when operating a closed record system? -
ANSWER>>1. Must be able to tell if records have been altered or invalid
,2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
6. Use operational system checks and restrictions
7. Use authority checks to make sure only authorized individuals are using the system
8. Use device checks to validate data input
9. Make sure those authorized to use system have appropriate training, education,
experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual system
What are some FDA standards to meet when using an Open System? - ANSWER>>All those
mentioned for the closed system.
1. Document encryption as appropriate
What information should a handwritten SIGNATURE block contain? - ANSWER>>1. Printed
name of signer
2. Date and Time when signature was executed
3. The MEANING associated with the signature (approval? responsibility? authorship?)
Signature and record linking ? - ANSWER>>Signatures must be linked to their respective
electronic records to make sure they cannot be copied, falsified, transferred etc.
, Do researchers need to request permission from the FDA to use electronic signatures in
place of regular signatures? - ANSWER>>Yes
What controls should an E-SIGNATURE contain? - ANSWER>>Employ at least 2
identification components - such as an identification code AND a password.
Name some CONTROLS for the identification components (i.e. identification code and
password) for e-signature? - ANSWER>>1. no 2 people should have the same identification
controls (password... code)
2. Identification codes and passwords should be periodically checked, revised, etc.
3. Deauthorize lost, stolen, missing codes and passwords
4. Periodically test your devices that generate these codes
Can an informed consent contain exculpatory language? - ANSWER>>NO! Cannot say
things like "you are waiving your right to damages" etc
When may an experimental drug or device be used on a patient WITHOUT informed
consent? ((EMERGENCY USE)) - ANSWER>>1. the investigator and an independent
physician agree that the patient is -life threatening situation
-informed consent cannot be obtained
- there is no time to obtain consent from th esubject's legal representation
-there is no recognized therapy that provides equal or greater likelihood of saving life
